Domestic biosimilar company Aprogen is showing strong performance on the 14th. This appears to reflect expectations of benefits following the European Medicines Agency (EMA)'s decision to simplify biosimilar approval processes.
As of 3:03 PM on the day, Aprogen's stock is trading at 762 KRW, up 8.39% compared to the previous trading day.
Recently, the EMA has been promoting measures to simplify the biosimilar approval procedure. If these measures are applied, biosimilar companies like Aprogen will be able to significantly reduce costs and shorten clinical trial periods.
In response, Aprogen announced that it is considering early termination of the ongoing Phase 3 clinical trial for its Herceptin biosimilar and immediately applying for product approval from the EMA. For the Humira biosimilar, for which Phase 1 and Phase 3 sample production has been completed, the plan is to swiftly conduct only Phase 1 clinical trials and apply for product approval.
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